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Fecal Microbiota Transplantation for Kidney Cancer (PERFORM Trial)
Phase 1
Waitlist Available
Led By Saman Maleki, PhD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance status (KPS) ≥70%
Ability to ingest capsules
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 9 years (end of study)
Awards & highlights
PERFORM Trial Summary
This trial is studying if Fecal Microbiota Transplantation (FMT) can help reduce side effects from a cancer immunotherapy drug combination.
Who is the study for?
This trial is for adults with advanced or metastatic renal cell carcinoma, specifically those at intermediate or poor risk. Participants must be in good physical condition (KPS ≥70%), able to swallow capsules, and have not had certain prior treatments including systemic therapy for RCC. Pregnant individuals, those with immunodeficiency, chronic intestinal diseases, active infections requiring systemic therapy, or a history of serious autoimmune disease are excluded.Check my eligibility
What is being tested?
The study tests if Fecal Microbiota Transplantation (FMT) can reduce the side effects of ipilimumab/nivolumab immunotherapy in kidney cancer patients. The goal is to allow patients to tolerate their cancer treatment better by altering gut bacteria before and during the first two cycles of this powerful but potentially toxic drug combination.See study design
What are the potential side effects?
Potential side effects from FMT may include discomfort at administration site and changes in bowel habits. Immunotherapy drugs like ipilimumab/nivolumab can cause inflammation in organs, fatigue, skin reactions, hormonal gland problems like thyroid issues, and could worsen pre-existing autoimmune conditions.
PERFORM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself but may not be able to do active work.
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I can swallow pills.
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My kidney cancer has spread and this was confirmed through tissue testing.
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My kidney cancer is classified as intermediate or poor risk.
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My blood tests show my organs and bone marrow are working well.
PERFORM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 9 years (end of study)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 9 years (end of study)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occurence of immune-related colitis associated with ipilimumab/nivolumab treatment
Secondary outcome measures
Changes in patient microbiome following FMT
Determine the effect on immune response
Health related quality of life
+4 moreOther outcome measures
Assess the immune profile of the tumor
Overall survival
Progression-free survival
Side effects data
From 2020 Phase 1 & 2 trial • 50 Patients • NCT0310684444%
Diarrhea
26%
Abdominal Pain
16%
Rectal Bleeding
12%
Constiption
10%
Fever
10%
Nausea
6%
Vomiting
6%
Fatigue
4%
Heart Burn
4%
Chills
4%
Migraine
4%
Yeast Infection
2%
Anemia
2%
IBD Flare
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment
PERFORM Trial Design
1Treatment groups
Experimental Treatment
Group I: Fecal Microbiota TransplantationExperimental Treatment1 Intervention
Fecal microbiota transplantation combined with approved standard of care treatment with nivolumab and ipilimumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplantation
2016
Completed Phase 2
~350
Find a Location
Who is running the clinical trial?
Academic Medical Organization of Southwestern OntarioOTHER
13 Previous Clinical Trials
2,529 Total Patients Enrolled
Lawson Health Research InstituteLead Sponsor
656 Previous Clinical Trials
413,408 Total Patients Enrolled
Saman Maleki, PhDPrincipal InvestigatorLawson Health Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had radiation for bone metastasis in the last 2 weeks or any radiation in the last 4 weeks.I have not received a live vaccine in the last 4 weeks.I am able to care for myself but may not be able to do active work.I will not need any other cancer treatment during the study.My side effects from previous treatments are mild or gone.I had cancer before, but I've been free of it for 5 years after treatment.I have an autoimmune disease that needs steroids or other immune-suppressing drugs.My brain metastases are stable after treatment.I cannot receive FMT due to specific health reasons.My kidney cancer has spread and this was confirmed through tissue testing.I can swallow pills.I have had lung inflammation treated with steroids or have it now.The doctor can measure the disease.I have had treatment for advanced kidney cancer that couldn't be surgically removed.My kidney cancer is classified as intermediate or poor risk.I have a long-term bowel disease.I am currently being treated for an infection.I have been diagnosed with an immune system disorder.I am not on high-dose steroids or any immunosuppressive drugs.My blood tests show my organs and bone marrow are working well.I am currently using antibiotics or have used them in the last two weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Fecal Microbiota Transplantation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total enrollment figure for this clinical investigation?
"Affirmative. Clinicaltrials.gov data indicates that this experiment, which was first made public on January 23rd 2020, is actively enrolling participants. 20 patients need to be enrolled at a single site."
Answered by AI
Is there capacity available to include more participants in this research endeavor?
"Affirmative, the information available on clinicaltrials.gov indicates that a recruitment drive for this trial is underway. It was posted online on January 23rd 2020 and edited most recently in April 5th 2022; 20 volunteers are required from one single medical site."
Answered by AI
Is Fecal Microbiota Transplantation a viable and secure therapy for patients?
"As Fecal Microbiota Transplantation is currently in its preliminary stages of research, with limited data supporting safety and efficacy; it has earned a rating of 1."
Answered by AI
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